Fish Oil to Prevent Asthma Exacerbations in Patients With ALOX5 Polymorphisms

NCT00621829 | Completed DMC

• 2 other identifiers: 200715569CHNR07702
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

This is a clinical study that is designed to study the effects of the supplemental intake of enriched omega-3 polyunsaturated fatty acids (fish oil) in patients with moderate to severe asthma. Some asthmatics produce a large amount of inflammatory leukotriene proteins-proteins that contribute to wheezing and inflammation in the airway. Inhibiting the detrimental effects of leukotrienes is a key goal of controller therapy in severe asthmatics. Some asthmatic patients appear to have specific mutations of the arachidonate 5-lipoxygenase (ALOX5) gene, one gene that regulates the production of the inflammatory leukotrienes. Omega-3 fatty acids can interfere with the arachidonic acid pathway and decrease the production of leukotrienes, and this may benefit moderate and severe asthma patients. Our hypothesis is that omega-3 fatty acid supplements, added on to a patient's asthma medication regimen, can decrease the number of minor asthma exacerbations compared to patients who do not receive the supplement. Furthermore, we believe that asthma patients with specific ALOX5 gene mutations will benefit most. We will enroll 30 asthma subjects to take part in this trial. They will undergo genotyping of the ALOX5 gene and be treated with omega3-fatty acids (fish oil) and placebo over a nine month period. We expect that this strategy will allow us to discover which moderate and severe asthma patients will benefit most from supplements of omega-3 fatty acids. Treatment of chronic diseases, such as asthma, is a key mission of the Center of Health and Nutrition Research.

Conditions

Asthma

Outcome Measures

Primary Outcomes (1)

• Asthma exacerbations

  3 months

Study Arms (2)

1

ACTIVE COMPARATOR

"High" susceptibility ALOX5 gene polymorphisms. Patients will be classified as having high susceptibility ALOX5 gene polymorphisms based on the number of repeats of the SP1 promoter.

Dietary Supplement: EPA enriched fish oils

2

ACTIVE COMPARATOR

"Low" susceptibility ALOX5 gene polymorphisms. "Low" susceptibility ALOX5 gene polymorphisms. Patients will be classified as having high susceptibility ALOX5 gene polymorphisms based on the number of repeats of the SP1 promoter.

Dietary Supplement: EPA enriched fish oils

Interventions

EPA enriched fish oils DIETARY_SUPPLEMENT

Subjects will take the (EPA)-enriched omega-3 polyunsaturated fatty acids (n3-PUFA) supplements as a capsule (3-4 g of EPA/day) for 90 days, followed by an 8 week washout period, and then will take a Placebo capsule for 90 days.

Also known as: The study agent, a single-ingredient preparation,, is a commercially prepared and marketed fish oil, concentrate produced by Ocean Nutrition Canada (ONC), Limited (http://www.ocean-nutrition.com/). This supplement, and related products are sold under the MEG-3® brand.

1

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Children and adults patients \>18 years or older with moderate and severe asthma (as diagnosed by lung specialist physician), based on the NIH NAEPP 1997 guidelines, who do not have an acute exacerbation at the time of enrollment and are on the same asthma medications for at least 1 month

You may not qualify if:

• Less than 18 years of age
• Baseline FEV1 \< 35% predicted
• Known or suspected allergy to fish oil products
• Pregnant women and nursing women
• Current smokers or subjects with a 20 pack-year history of smoking

Sponsors & Collaborators

• University of California, Davis: lead
• National Institutes of Health (NIH): collaborator

Study Sites (1)

Ucdmc/Vanchcs Ccrc

Mather, California, 95655, United States

Location

MeSH Terms

Conditions

Asthma

Interventions

Fatty Acids, Omega-3; Fish Oils

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Intervention Hierarchy (Ancestors)

Dietary Fats, Unsaturated; Dietary Fats; Fats; Lipids; Fatty Acids, Unsaturated; Fatty Acids; Oils

Study Officials

• Charles Stephensen, Ph.D.

  USDA, Staff Scientist

  STUDY DIRECTOR

• Nicholas Kenyon, MD

  University of California, Davis

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 12, 2008
• First Posted: February 22, 2008
• Study Start: February 1, 2008
• Primary Completion: October 1, 2011
• Study Completion: October 1, 2011
• Last Updated: May 15, 2017

Record last verified: 2017-05

Locations

US (1)